IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Specific Aim
研究概览
简要总结
This research is being done to determine if a short course of Chloroquine (five weeks) before, during and after whole brain radiation therapy (WBRT) will improve the overall survival of subjects being treated for brain metastases.
详细描述
Hypothesis one: A short course of chloroquine one week prior and four weeks after initiation of WBRT is tolerable and significantly increases the median survival time of patients suffering from brain metastasis as assessed one, three, six, nine, twelve and 24 months post radiotherapy, when compared to historic controls.
Hypothesis two: The presence of one or both single-nucleotide polymorphisms (SNP)s in the gene coding for the immunoregulatory enzyme indoleamine 2,3-dioxygenase 2 (IDO2) improves the clinical outcomes of WBRT or the response to CQ co-treatment.
3.2. Specific Aims:
The specific aims of this study are:
- Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy.
- Record the status of patient metastases (i.e. number, location, size)
- Determine patients' KPS values.
- Record the incidence and causes of mortality of patients.
- Determine the genotype of IDO2 for each patient.
- Following data analysis, test the validity of the two hypotheses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed primary solid malignancy
- •Patients with single or multiple brain metastases
- •Patients with metastasis diameter < 5 cm
- •Age > 18
- •Clearance from the patient's physician that treatment with chloroquine should not pose a problem to the patient
排除标准
- •Patients with a history of hypotension, cardiomyopathy, epilepsy, seizures
- •Patients with impaired renal function
- •Patients with psoriasis, porphyria
- •Patients with known hypersensitivity to 4-aminoquinoline compounds
- •Pregnancy, nursing
- •Prior radiotherapy
- •During the chloroquine treatment, patients complaining from visual or auditory disturbances, and patients suffering from acute gastrointestinal problems i.e. Anorexia, nausea, vomiting, diarrhea, abdominal cramps
研究组 & 干预措施
CQ Arm
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.
干预措施: Chloroquine diphosphate (Drug)
结局指标
主要结局
Specific Aim
时间窗: up to 24-months after completion of treatment
Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy
次要结局
- Secondary endpoint: death(up to 24 months after completion of treatment)
研究者
Albert DeNittis
Principal Investigator
Main Line Health